Actively Recruiting
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
Led by EndoQuest Robotics, Inc. · Updated on 2026-04-14
56
Participants Needed
6
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
CONDITIONS
Official Title
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older at the time of consent
- Body mass index (BMI) of 50 kg/m2 or less
- American Society of Anesthesiologists (ASA) score of 3 or less
- Presence of benign lesion(s) in the rectum or sigmoid colon such as adenoma with low- or high-grade dysplasia, neuroendocrine tumor, or other types of polyps
- Lesion size 7 cm or less and involving 75% or less of the colorectal circumference
- Eligible for standard endoscopic submucosal dissection
- Signed informed consent to participate in the study
You will not qualify if you...
- Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- Active left-sided inflammatory bowel disease
- Untreated active infection at the time of the procedure
- Part of a vulnerable population (e.g., prisoners, mentally disabled)
- Severe concomitant illness that shortens life expectancy or increases risk of interventions
- Breastfeeding, pregnant, or intending to become pregnant during the study
- Currently enrolled or recently discontinued (within 30 days) from another incompatible clinical trial
- Ejection fraction (EF) 45 or less, high cardiac or pulmonary risk without clearance
- On blood thinners that cannot be stopped before surgery
- Moderately or severely immunocompromised
- Unable to comply with study protocol or deemed unsuitable by the Investigator
- Inadequate bowel preparation
- Complex anatomy not suitable for endoluminal approach
- Anatomical narrowing below the lesion site
- Lesion not located in the rectum or sigmoid colon
- Lesion larger than 7 cm or occupying more than 75% of colorectal circumference
- Lesion showing signs suggestive of invasive cancer
- Unsuitable anatomy or subject for study device use
- Lesion location not accessible by the study device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
AdventHealth
Orlando, Florida, United States, 32803
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Completed
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
HCA Healthcare
Houston, Texas, United States, 77004
Actively Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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